Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

  • STATUS
    Recruiting
  • End date
    Jun 4, 2026
  • participants needed
    15
  • sponsor
    Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Updated on 4 May 2022
remission
consolidation therapy

Summary

The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.

Description

Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.

Details
Condition Acute Myeloid Leukemia
Treatment Expanded haploidentical NK cells
Clinical Study IdentifierNCT05334693
SponsorBelarusian Research Center for Pediatric Oncology, Hematology and Immunology
Last Modified on4 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients
primary intermediate risk AML in molecular complete remission
primary high risk AML in molecular complete remission awaiting unrelated HSCT
Karnofsky or Lansky performance scale greater or equal to 70
written informed consent
Donors
haploidentical family donor
donor suitable for cell donation and apheresis according to standard criteria
written informed consent

Exclusion Criteria

Patients
uncontrolled infection
severe hepatic dysfunction: SGOT or SCPT >=5x upper limit of normal for age
positive serology for human immunodeficiency virus (HIV)
Donors
pregnancy
positive serology for HIV, hepatitis B or C
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